Combining dutasteride with hormone therapy for salivary duct carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates the effectiveness of adding dutasteride to combined androgen blockade (CAB) therapy in patients with recurrent and/or metastatic salivary duct carcinoma. The study includes two cohorts: ADT-naïve patients and ADT-resistant patients, with the former cohort closed for inclusion as of April 2024. Participants will be randomized to receive either CAB or CAB plus dutasteride, and the trial aims to assess various outcomes including response rates, survival, toxicity, and quality of life. Treatment continues until disease progression, intolerable toxicity, or withdrawal by the patient or investigator.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologically/histologically proven diagnosis of (incurable) AR+ R/M salivary duct carcinoma
* AR positive diseases (strong expression in at least 1% of nuclei of neoplastic cells based on central IHC review)
* Measurable disease per RECIST version 1.1 at baseline. Appendix II.
* Age ≥ 18 years
* Written informed consent must be given according to national/local regulation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix III).
* Adequate bone marrow function:
* WBC ≥ 3.5/10\^9 /L
* Absolute neutrophil count (ANC) ≥ 1.5x10\^9/L
* Hemoglobin ≥ 6.20 mmol/L
* Platelet count ≥ 100x10\^9/L
* Adequate liver function:
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN) OR ≤ 5.0 times ULN for patients with liver metastases
* Bilirubin ≤ 1.5 times ULN. For patients known with Gilbert's Syndrome ≤ 3.0 times ULN is permitted.
* Adequate renal function:
* Serum creatinine level ≤ 1.5 times ULN or calculated creatinine clearance ≥ 30 mL/min based on CKD-EPI-GFR
* Adequate cardiac function

Exclusion Criteria:

* Patients with history of allergic reactions attributed to compounds of similar chemical or biological composition to goserelin, bicalutamide or dutasteride
* Patients with peanut or soy allergy (dutasteride capsules contain lecithin which may contain soy oil)
* Patients who do not have adequate swallowing capacity
* Patients familiar with Long QT-syndrome (LQTS)
* Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
* Patients that are pregnant or lactating
* Patients with uncontrolled illness including:
* Cardiovascular disorders, including symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias
* Uncontrolled hypertension (defined as sustained systolic BP \> 160 mm Hg, or diastolic BP \> 100 mm Hg. Unless evidence of white-coat hypertension)
* Stroke (including TIA), myocardial infarction, or other ischemic event within 6 months before inclusion
* Serious active infections
* Patients undergoing concomitant treatments including:
* Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation
* Concomitant (or within 6 months before inclusion) administration of any 5-alpha reductase inhibitor, i.e. dutasteride or finasteride
* Concurrent treatment with any other anti-cancer therapy within the last 4 weeks before inclusion
* Curative radiation therapy within the last 4 weeks before inclusion or palliative radiation therapy 1 week before start of study
* Any condition which, in the opinion of the investigator, would preclude participation in this clinical study

Where it's running

• Radboudumc
  Nijmegen, Gelderland, Netherlands Recruiting

Study contacts

• Principal investigator: C.M.L. van Herpen, prof. MD. PhD. — Radboud University Medical Center
• Study coordinator: C.M.L. Van Herpen, Prof. MD. PhD.
• Email: Jetty.Weijers@radboudumc.nl
• Phone: +31243611111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.